Viatris Announces Exclusive Licensing Agreement with Lexicon Pharmaceuticals for Sotagliflozin in all Markets Outside of the U.S. and Europe

VTRS 10.16.2024

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PITTSBURGH,Oct. 16, 2024/PRNewswire/ --Viatris Inc. (Nasdaq: VTRS), a global healthcare company, today announced it has entered into an exclusive licensing agreement withLexicon Pharmaceuticals, Inc.(Nasdaq: LXRX) for sotagliflozin in all markets outside ofthe United StatesandEurope.

Sotagliflozin was approved by theU.S. Food and Drug AdministrationinMay 2023to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors.

This licensing agreement leveragesViatris'expertise in cardiovascular diseases and its Global Healthcare Gateway®— which offers partners ready access to more markets and patients worldwide through the Company's unique global infrastructure and expertise. This transaction is another example of how the Company is continuing to expand its innovative portfolio by identifying, vetting and securing highly innovative, patent-protected assets that address significant unmet medical needs.

ViatrisChief Commercial OfficerCorinne Le Goffsaid: "This licensing agreement with Lexicon adds another asset to our expanding innovative portfolio in cardiovascular diseases which gives us the opportunity to further drive accelerated and durable revenue growth in the future. We believe we will be able to leverage our strong foundation in cardiovascular diseases and our unique infrastructure to execute on the potential of sotagliflozin. We look forward to working with Lexicon to make a real difference and expand access for patients."

Lexicon CEO and Director, Dr.Mike Eaton, Ph.D., said: "We are pleased to be working withViatris, a company with strong cardiometabolic expertise, global commercial capabilities and a successful track record of launching medicines in new territories. We are confident that this agreement will expand the reach of sotagliflozin to more patients in need. Partnering with high quality companies to support commercialization of our medicines globally is a critical pillar of ourLead to Succeedstrategy at Lexicon. We plan to continue to evaluate strategic partnerships for additional assets, territories and indications to augment Lexicon's development and commercial capabilities, advance our pipeline and expand access of our medicines to more patients around the world."

Terms of the TransactionUnder the terms of the agreement,Viatriswill acquire rights to sotagliflozin in all global markets outside of theU.S.andEuropein exchange for an upfront payment to Lexicon of$25 million, and additional potential contingent payments, including regulatory milestones, sales milestones and tiered royalties ranging from low-double-digit to upper-teens on annual net sales. Viatris will be responsible for all regulatory and commercialization activities for sotagliflozin in the licensed territories. Lexicon will be responsible for providing clinical and commercial supply of sotagliflozin toViatris.Viatriscurrently expects to account for the transaction as an asset acquisition, with the upfront payment being expensed as in-process research and development.

About SotagliflozinSotagliflozin is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose and sodium reabsorption by the kidney and SGLT1 is responsible for glucose and sodium absorption in the gastrointestinal tract. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients.

AboutViatrisViatris Inc. (NASDAQ: VTRS) is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. With our exceptionally extensive and diverse portfolio of medicines, a one-of-a-kind global supply chain designed to reach more people when and where they need them, and the scientific expertise to address some of the world's most enduring health challenges, access takes on deep meaning atViatris. We are headquartered in theU.S., with global centers inPittsburgh,ShanghaiandHyderabad, India. Learn more atviatris.comandinvestor.viatris.com, and connect with us onLinkedIn,Instagram,YouTubeandX(formerly Twitter).

AboutLexicon PharmaceuticalsLexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients' lives. Through its Genome5000TM program, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. Lexicon is commercially launching one of these medicines, INPEFA® (sotagliflozin) inthe United States, and has a pipeline of other promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, diabetes and metabolism and other indications. For additional information, please visitwww.lexpharma.com.

Forward-Looking StatementsThis press release includes statements that constitute "forward-looking statements." These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward looking statements may include statements that this continues to expandViatris'innovative portfolio in cardiovascular diseases; this licensing agreement leveragesViatris'expertise in cardiovascular diseases and its Global Healthcare Gateway®— which offers partners ready access to more markets and patients worldwide through the Company's unique global infrastructure and expertise; this transaction is another example of how the Company is continuing to expand its innovative portfolio by identifying, vetting and securing highly innovative, patent-protected assets that address significant unmet medical needs; this licensing agreement with Lexicon adds another asset to our expanding innovative portfolio in cardiovascular diseases which gives us the opportunity to further drive accelerated and durable revenue growth in the future; we believe we will be able to leverage our strong foundation in cardiovascular diseases and our unique infrastructure to execute on the potential of sotagliflozin; we look forward to working with Lexicon to make a real difference and expand access for patients; and the terms of the transaction. Because forward-looking statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: actions and decisions of healthcare and pharmaceutical regulators; changes in healthcare and pharmaceutical laws and regulations in theU.S.and abroad; any regulatory, legal or other impediments toViatris'ability to bring new products to market, including but not limited to "at-risk" launches;Viatris'or its partners' ability to develop, manufacture, and commercialize products; the scope, timing and outcome of any ongoing legal proceedings, and the impact of any such proceedings; the possibility thatViatrismay be unable to realize the intended benefits of, or achieve the intended goals or outlooks with respect to, its strategic initiatives; the possibility thatViatrismay be unable to achieve intended or expected benefits, goals, outlooks, synergies, growth opportunities and operating efficiencies in connection with divestitures, acquisitions, other transactions or restructuring programs, within the expected timeframes or at all; goodwill or impairment charges or other losses related to the divestiture or sale of businesses or assets;Viatris'failure to achieve expected or targeted future financial and operating performance and results; the potential impact of public health outbreaks, epidemics and pandemics; any significant breach of data security or data privacy or disruptions to our information technology systems; risks associated with international operations; the ability to protect intellectual property and preserve intellectual property rights; changes in third-party relationships; the effect of any changes inViatris'or its partners' customer and supplier relationships and customer purchasing patterns; the impacts of competition; changes in the economic and financial conditions ofViatrisor its partners; uncertainties and matters beyond the control of management, including general economic conditions, inflation and exchange rates; failure to execute stock repurchases consistent with current expectations; stock price volatility; and the other risks described inViatris'filings with theSecurities and Exchange Commission(SEC).Viatrisroutinely uses its website as a means of disclosing material information to the public in a broad, non-exclusionary manner for purposes of theSEC'sRegulation Fair Disclosure (Reg FD).Viatrisundertakes no obligation to update these statements for revisions or changes after the date of this press release other than as required by law.

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SOURCEViatris Inc.

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